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    Summary
    EudraCT Number:2012-000967-25
    Sponsor's Protocol Code Number:ThoRaT
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-05-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNorway - NOMA
    A.2EudraCT number2012-000967-25
    A.3Full title of the trial
    Concomitant Radiotherapy and Erlotinib in advanced lung cancer

    ThoRaT-studien
    Thoracal Radiotherapy and Tarceva®

    An open randomized multicenter phase II study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Concomitant Radiotherapy and Erlotinib in advanced lung cancer

    ThoRaT-studien
    Thoracal Radiotherapy and Tarceva®

    An open randomized multicenter phase II study
    A.3.2Name or abbreviated title of the trial where available
    ThoRaT
    A.4.1Sponsor's protocol code numberThoRaT
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTarceva
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-small cell lung cancer, - palliative treatment
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Endpoints:
    Primary:
    • To determine if erlotinib given orally along with concurrent external beam radiation therapy, prolongs local tumour control as determined by CT evaluation compared to treatment with external beam radiation therapy alone
    • To determine whether continued administration of erlotinib prolongs local control


    Secondary
    • To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy.
    • To evaluate if erlotinib along with concurrent external beam radiation therapy, improves quality of life as assessed with the EORTC QLQ-C30 and the EORTC QLQ-LC13.
    • To evaluate if PET-CT examination can be used to predict response to treatment.
    • To evaluate overall survival in the different groups
    E.2.2Secondary objectives of the trial
    Endpoints:
    Primary:
    • To determine if erlotinib given orally along with concurrent external beam radiation therapy, prolongs local tumour control as determined by CT evaluation compared to treatment with external beam radiation therapy alone
    • To determine whether continued administration of erlotinib prolongs local control


    Secondary
    • To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy.
    • To evaluate if erlotinib along with concurrent external beam radiation therapy, improves quality of life as assessed with the EORTC QLQ-C30 and the EORTC QLQ-LC13.
    • To evaluate if PET-CT examination can be used to predict response to treatment.
    • To evaluate overall survival in the different groups
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion crieteria
    • Age >18 years
    • Histological or cytological verified NSCLC
    • ECOG Performance status 0-2
    • Fertile patients must use contraception
    • Signed informed consent
    • Ability to understand and fill in QoL questionnaires
    • Capability to take per os medication
    • Serum bilirubin < 2 times upper limit of normal (ULN)
    • AST and ALT < 2 times ULN (< 5 times ULN if liver metastases are present)
    • Creatinine < 5 times ULN
    E.4Principal exclusion criteria
    Exclusion criteria
    • Pregnancy or nursing
    • Other prior or concurrent malignant disease likely to interfere with study treatment or comparisons
    • No evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications
    • No prior radiotherapy to the same organ / place
    • No concurrent treatment with other experimental drugs
    • Known brain metastases in need of radiotherapy
    E.5 End points
    E.5.1Primary end point(s)
    Endpoints:
    Primary:
    • To determine if erlotinib given orally along with concurrent external beam radiation therapy, prolongs local tumour control as determined by CT evaluation compared to treatment with external beam radiation therapy alone
    • To determine whether continued administration of erlotinib prolongs local control


    Secondary
    • To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy.
    • To evaluate if erlotinib along with concurrent external beam radiation therapy, improves quality of life as assessed with the EORTC QLQ-C30 and the EORTC QLQ-LC13.
    • To evaluate if PET-CT examination can be used to predict response to treatment.
    • To evaluate overall survival in the different groups
    E.5.1.1Timepoint(s) of evaluation of this end point
    6-8 weeks after treatment, 12-14 weeks after treatment, 20-26 weeks after treatment, 40-52 weeks after treatment
    E.5.2Secondary end point(s)
    Endpoints:
    Primary:
    • To determine if erlotinib given orally along with concurrent external beam radiation therapy, prolongs local tumour control as determined by CT evaluation compared to treatment with external beam radiation therapy alone
    • To determine whether continued administration of erlotinib prolongs local control


    Secondary
    • To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy.
    • To evaluate if erlotinib along with concurrent external beam radiation therapy, improves quality of life as assessed with the EORTC QLQ-C30 and the EORTC QLQ-LC13.
    • To evaluate if PET-CT examination can be used to predict response to treatment.
    • To evaluate overall survival in the different groups
    E.5.2.1Timepoint(s) of evaluation of this end point
    6-8 weeks after treatment, 12-14 weeks after treatment, 20-26 weeks after treatment, 40-52 weeks after treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Radiotherapy alone
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    patients are followed until death or until they do not want more follow-ups
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    F.2 Gender
    F.2.1Female No
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state225
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Follow-up as standard.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-27
    P. End of Trial
    P.End of Trial StatusOngoing
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